The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
- Registration Number
- NCT01412372
- Lead Sponsor
- University of Utah
- Brief Summary
The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.
- Detailed Description
This study will test long acting mesalamine in the management of PI-IBS. It has the potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of this study, if positive, will provide preliminary data for a large scale clinical trial.
This study will also provide information about plasma cytokines in patients with PI-IBS and whether improvement in symptoms correlates with improvement in plasma cytokines.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
- Men and women age 18-75 years
- Rome III criteria for IBS
- Symptom onset after apparent acute gastroenteritis
- Symptoms of 6 months or greater duration
- Normal gross appearance of the colonic mucosa other than erythema
- Negative markers for celiac disease and inflammatory bowel disease
- Normal thyroid function and serum calcium
- Stable medication regimens for other medical conditions.
- Age <18 or >75 years
- Previous diagnosis of or history compatible with IBS
- Constipation-predominant IBS.
- Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
- History of/or presence of malignancy
- Current evidence of any gastrointestinal disorder such as celiac disease, inflammatory bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or colonic resection, paraplegia or quadriplegia. .
- Current evidence of drug or alcohol abuse as judged by the investigator
- Allergy to mesalamine or aspirin
- Investigator perception of patient's inability to comply with the study protocol
- Unstable psychiatric disease
- Recent change in gastrointestinal medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo This arm will include those who are randomized to the placebo Mesalamine Mesalamine This arm is for subjects randomized to the study drug, Mesalamine
- Primary Outcome Measures
Name Time Method Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period Baseline and 8 weeks BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
- Secondary Outcome Measures
Name Time Method Change in Average Bowel Frequency After 8-Week Treatment Period Baseline and 8 weeks Measured by the participant reported average number of daily bowel movements.
Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period. Baseline and 8 weeks As measured by the IBS specific Quality of Life questionnaire which consists of 34 items scored on a scale of 0% to 100%, 0 being not at all and 100 being extremely.
Change in Average Bowel Consistency Score After an 8 Week Treatment Period. Baseline and 8 weeks Measured using the Bristol Stool form scale 1-7, with 1 being the most formed and 7 the least formed.
Change in Average Abdominal Pain Score After an 8 Week Treatment Period Baseline and 8 weeks Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Change in Average Bloating Score After an 8 Week Treatment Period. Baseline and 8 weeks Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Trial Locations
- Locations (1)
University of Utah
🇺🇸Salt Lake City, Utah, United States